Ce Marking

The letters ‘CE’ refers to the French abbreviation "Conformité Européene" and it may appear on many products that are traded on the extended Single Market in the European Economic Area (EEA). This marking is referred as the CE Marking. The EEA composed of the EU countries along with Iceland Liechtenstein, Norway and Switzerland.

CE Marking presence on a product referred as the declaration of the manufacturer that the product meets the standards and legal requirements to be marketed on the EEA. This condition also applies to the products from the other countries which are to be sold in the EEA Market. The CE Mark implies that the products sold in the single Market of EEA have complied to meet all safety, health and environmental protection requirements. Any products bought within the EEA possess the CE mark on them. CE marking in a way promotes fair competition on the market as all companies are accountable to the same rules. The manufacturer or the manufacturer himself is responsible for verifying compliance with the directives and affixing the CE marking.

“The main benefits that the CE marking brings to the businesses and consumers within the EEA are:

• Businesses know that products bearing the CE marking can be traded in the EEA without restrictions.
• Consumers enjoy the same level of health, safety, and environmental protection throughout the EEA”.

To affix the product with the CE Mark the Manufacturers follows the set of documents from the European Union known as Product Directives.

Product Directives are the documents that contain requirements and regulation the product should comply with. Not all products should be affixed with the CE marking. It is compulsory only for the products that need to be marketed within EEA and covered by the Product Directives. The product directives are classified based on the industrial sector the product being used. It is forbidden to affix CE marking to the products that does not fall under any product directives. Depending on the nature of the product the product falls under one or more than one product directives. Product directives consist of a rules and regulation for the product to be manufactured. Some product directives which cover large product ranges provide a set of standards for the product should conform; these standards are referred to as "Harmonized Standards". Harmonized Standards are the documents that list the technical specifications and test methods to verify the products to conform to the technical specification. Harmonized Standards are established by several European standards agencies (CEN, CENELEC, etc).

CE Marking also provides some advantages on the single market area of EEA making it simpler for the trading of products in the market. The marking on a product indicates the governmental officials of any country to verify that the product is legally or illegally placed on the market of their country. CE Marking on a product ensures the free movement of the product within the Single market area providing equal opportunities and equal standards to the Manufacturers and safe market to the consumers. CE Marking on a product also promotes the permission of withdrawal of the non-conforming products by EEA Customs.

Manufacturers

As CE Marking sole purpose is have a single market area with products of good quality and safety standards. The manufacturers play an important role in ensuring that products placed on this Market of the EEA meets those standards. They are responsible for ensuring that the products from them which are placed on the market meet the standards of EU safety, health, and environmental protection requirements.

To ensure the product with EU standards, manufacturers have to carry out the conformity assessment and issue the EU declaration of conformity before affixing the CE marking to a product. Only after the conformity assessment, the technical file of the product can be set up which supports the EU conformity declaration so that this product can be traded on the market. The conformity assessment can be done by the manufacturer themselves or by a notified body which is appointed by the national authorities. “Manufacturers have to follow these six steps to affix a CE marking to your product: Identify the applicable directive(s) and harmonized standards. Verify the specific requirements for the product. Identify whether an independent conformity assessment (by a notified body) is necessary. Test the product and check its conformity. Draw up and keep available the required technical documentation. Affix the CE marking and draw up the EU Declaration of Conformity.”

The above steps may differ according to the product as the conformity assessment procedure of the products varies mostly. Manufacturers should not affix CE marking to other products that does not fall under any of the directives as it is forbidden to do so.

Conformity assessment

The main objective of the European Commission is to ensure that the unsafe and non-compliant products should not enter the European Market. The conformity assessment is the process to ensure the standards of the product. The conformity assessment procedure is carried out on the product before the product enters the market. This procedure should provide the requirements that are met by the product. The assessment comprises of the testing, inspection and providing the technical certification of the product for the conformity. The test methods and procedure of the assessment are specified in the applicable harmonized standards of the product. The manufacturer can choose the procedure types from the directives if applicable. The assessment can be done by the manufacturer or by an independent organization known as notified bodies which are appointed by the national authorities.

If the manufacturers carry out the assessment by themselves, the most used assessment method is internal production control which is given as follows.

• Accessing and ensuring the list of directives and standards for the product.
• Create the requirements that should be fulfilled by the product.
• Create of the test plan and procedures according to the harmonized standards.
• Testing and verification of the product with requirement.
• Create Technical file or Technical documentation for the Conformity.
• Manufacturers draw up a written EU declaration of conformity to the authorities.
• Affix a proper CE Marking to the product according to the EU Commission.

The technical documentation that supports the conformity of the product varies with some products but the following documents are the most important in the technical documentation:

• A general description of the device, sometimes including photographs showing external features, Software versions, user information and installation manuals.
• Designs, manufacturing drawings and plans of components, assemblies, circuits.
• Descriptions and explanations necessary for the understanding of the drawings, plans and functioning.
• A list of harmonized standards applied for the products in full or in parts.
• Results of design calculations and tests.
• Test reports.